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vor 3 Wochen
Bacthera is a leading contract development and manufacturing partner (CDMO) for biotech and pharma customers. We enable our customers to bring life-changing treatments to patients. We operate from our headquarters in Basel (CH) and have production facilities in Denmark and Switzerland. We bring together best-in-class, complementary capabilities and we are the first CDMO globally to provide a full supply chain that offers manufacturing of live bacteria strains for therapeutic use.
Create your own future as:
**QA Manager (f/m/d) 100%**:
The QA Manager, as a member of the QA Unit, be involved in the commissioning, qualification and process validation of a new manufacturing facility and in the establishment of the quality management system and process, thus ensuring Quality oversight and compliance with national/international requirements and cGMP standards.
**My main tasks will be**:
- Being involved in all quality related activities for the manufacturing processes
- Responsible for review and approval of documents such as Standard Operating Procedures, Master Manufacturing Batch Records, Deviations Reports, Change Requests, Qualification/Validation Protocols and Reports etc.
- Ensures all manufacturing related deviations are appropriately investigated and recorded
- Directs the investigations of customer product complaints and assures the timely completion of the appropriate documentation
- Being responsible to drive CAPA and effectiveness check items to completion and timely closing
- Performs Batch record reviews for Drug Substance and Drug Product on behalf of the Responsible Person
- Evaluates product-related changes, assesses relevance to regulatory filings, provides change notifications for endorsement to customers where required and approves the change requests
- Ensures an efficient GMP compliant life cycle management of all products manufactured
- Represents QA in project/tech transfer teams for new manufacturing processes
- Supports and approves project/product specific risk assessments
- Is involved and supports internal and external audits (incl. inspections by health authorities)
- Identifies emerging QA relevant topics, communicates to the organization and works actively on their development into new or already established Quality and Compliance strategies and/or standards
- Supports GMP training programs to ensure staff is being trained
- Actively supports the Quality culture as a role model
**I bring with me**:
- Bachelor degree, Master degree in biotechnology, pharmacy, life science or related field.
- More than 3 years of experience in the GMP regulated pharmaceutical industry, preferably in a quality and compliance role in production and CAPEX projects.
- Strong background GMP regulations.
- Strong team orientation.
- Structured, focused and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive.
- Solution-oriented.
- Experienced in representing Quality and Compliance in the operational manufacturing environment.
- General knowledge of manufacturing processes and analytical methods.
- Ability to oversee project execution to identify non-compliance from quality standards.
- Ability to prioritize and manage work to critical project timelines in a fast-paced environment.
- A good operational level of both English and German
**My Reasons for choosing Bacthera**:
- Innovative and fast-growing start-up company with short decision-making processes
- Flexible working hours (possibility of Home Office)
- Motivated, agile and multinational team
- Very good pension fund and attractive salary
- Fringe benefits (e.g. Lunch card, deduction at different stores, Job ticket for public transport)
- Interesting and diversified tasks
**This is the opportunity to be part of a fast-growing start-up company, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting to you, we are looking forward to learn more about you.**
Céline Künzi
HR Business Partner
